Lipocine Completes Dosing in Key Postpartum Depression Study of LPCN 1154

Lipocine Inc., a biopharmaceutical company listed on NASDAQ under the ticker LPCN, has completed the dosing phase in a pivotal pharmacokinetic (PK) study aimed at supporting a New Drug Application (NDA) for LPCN 1154. This oral formulation of brexanolone is being developed to treat postpartum depression (PPD). The company expects to report topline results from the study late in the second quarter of 2024 and aims to submit the NDA by the end of the fourth quarter of the same year.

Dr. Mahesh Patel, President and CEO of Lipocine, expressed satisfaction with the completion of the dosing phase and anticipates sharing the study's results soon.

Postpartum depression is a significant depressive disorder that begins either during pregnancy or within the first four weeks after childbirth. Symptoms can last up to a year post-delivery. There is a pressing need for an oral medication that acts quickly and has an enhanced safety and efficacy profile for treating PPD. LPCN 1154 is being developed to meet this need, offering rapid relief and robust efficacy with a 48-hour outpatient dosing regimen.

Recent data indicates that the market for PPD treatments is larger than previously thought, with around 500,000 women in the United States affected annually. The Centers for Disease Control and Prevention (CDC) estimates that 175,000 women suffer from moderate to severe PPD. Increased awareness among healthcare providers and patients is expected to lead to higher diagnosis rates and more women seeking treatment.

Lipocine has received FDA acceptance of a 505(b)(2) NDA filing, facilitated by a single pivotal PK study that compares the exposure of LPCN 1154 to the approved intravenous (IV) infusion of brexanolone.

LPCN 1154 is a bioidentical neuroactive steroid designed for oral administration to provide rapid relief from postpartum depression. Brexanolone, the active ingredient, is identical to the naturally occurring neuroactive steroid allopregnanolone, which modulates the GABA receptor. LPCN 1154 aims to offer benefits such as rapid symptom improvement with minimal risk to breastfed infants exposed to brexanolone.

PPD's symptoms include sadness, loss of interest, changes in appetite, fatigue, and thoughts of self-harm or suicide. Approximately 20-40% of obstetric patients may experience PPD, according to a recent survey. Traditional antidepressants, often prescribed for PPD, are not specifically approved for this condition and have limitations such as delayed onset and side effects.

Lipocine is a biopharmaceutical company focusing on the development of therapies for central nervous system (CNS) disorders. The company leverages its proprietary technology to create differentiated products with favorable benefit-risk profiles. In addition to LPCN 1154 for PPD, Lipocine is developing several other drug candidates, including LPCN 2101 for epilepsy, LPCN 2203 for essential tremor, LPCN 2401 for chronic weight management, and LPCN 1148 for liver cirrhosis symptoms.

Lipocine is also exploring partnership opportunities for some of its candidates. TLANDO, an oral prodrug of testosterone developed by Lipocine, has received FDA approval for treating hypogonadism in adult males.

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